Cialis
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Cialis (tadalafil) is a phosphodiesterase inhibitor used for treating impotence (erectile dysfunction, or ED). Common side effects of Cialis include:
- flushing (redness or warmth of the face, neck, or chest),
- headaches,
- stomach upset,
- diarrhea,
- flu-like symptoms (such as stuffy nose, sneezing, or sore throat),
- memory problems,
- muscle or back pain,
- nausea,
- low blood pressure,
- dizziness,
- blurred vision and changes in color vision,
- abnormal ejaculation, and
- prolonged erections (priapism).
Tell your doctor if you have rare but serious side effects of Cialis including:
- a painful or prolonged erection lasting 4 or more hours;
- sudden decreased vision (including permanent blindness, in one or both eyes);
- a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness.
The recommended dose of Cialis is 5-20 mg per day taken before sexual activity. Cialis may interact with rifamycins, antibiotics, antifungals, antidepressants, barbiturates, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, HIV or AIDS medications or seizure medications. Tell your doctor all medications and supplements you use. Cialis is not approved for use in women and has not been evaluated in women who are breastfeeding.
Our Cialis Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SL >Erectile Dysfunction (ED) Causes and Treatment See Slideshow
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tadalafil and call your doctor at once if you have:
- heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- vision changes or sudden vision loss;
- ringing in your ears or sudden hearing loss; or
- an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).
Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.
Common side effects may include:
- headache;
- flushing (warmth, redness, or tingly feeling);
- nausea, upset stomach;
- runny or stuffy nose; or
- muscle pain, back pain, pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cialis (Tadalafil)
QUESTION
S >Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
CIALIS For Use As Needed For ED
In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.
When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for CIALIS for use as needed:
Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed for ED
| Adverse Reaction | Placebo (N=476) |
Tadalafil 5 mg (N=151) |
Tadalafil 10 mg (N=394) |
Tadalafil 20 mg (N=635) |
| Headache | 5% | 11% | 11% | 15% |
| Dyspepsia | 1% | 4% | 8% | 10% |
| Back pain | 3% | 3% | 5% | 6% |
| Myalgia | 1% | 1% | 4% | 3% |
| Nasal congestion | 1% | 2% | 3% | 3% |
| Flushing a | 1% | 2% | 3% | 3% |
| Pain in limb | 1% | 1% | 3% | 3% |
| a The term flushing includes: facial flushing and flushing |
CIALIS For Once Daily Use For ED
In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.
The following adverse reactions were reported (see Table 2) in clinical trials of 12 weeks duration:
Table 2: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes) for CIALIS for Once Daily Use for ED
| Adverse Reaction | Placebo (N=248) |
Tadalafil 2.5 mg (N=196) |
Tadalafil 5 mg (N=304) |
| Headache | 5% | 3% | 6% |
| Dyspepsia | 2% | 4% | 5% |
| Nasopharyngitis | 4% | 4% | 3% |
| Back pain | 1% | 3% | 3% |
| Upper respiratory tract infection | 1% | 3% | 3% |
| Flushing | 1% | 1% | 3% |
| Myalgia | 1% | 2% | 2% |
| Cough | 0% | 4% | 2% |
| Diarrhea | 0% | 1% | 2% |
| Nasal congestion | 0% | 2% | 2% |
| Pain in extremity | 0% | 1% | 2% |
| Urinary tract infection | 0% | 2% | 0% |
| Gastroesophageal reflux disease | 0% | 2% | 1% |
| Abdominal pain | 0% | 2% | 1% |
The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study:
Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for CIALIS for Once Daily Use for ED
| Adverse Reaction | Placebo (N=94) |
Tadalafil 2.5 mg (N=96) |
Tadalafil 5 mg (N=97) |
| Nasopharyngitis | 5% | 6% | 6% |
| Gastroenteritis | 2% | 3% | 5% |
| Back pain | 3% | 5% | 2% |
| Upper respiratory tract infection | 0% | 3% | 4% |
| Dyspepsia | 1% | 4% | 1% |
| Gastroesophageal reflux disease | 0% | 3% | 2% |
| Myalgia | 2% | 4% | 1% |
| Hypertension | 0% | 1% | 3% |
| Nasal congestion | 0% | 0% | 4% |
CIALIS For Once Daily Use For BPH And For ED And BPH
In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with tadalafil was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported (see Table 4).
Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with CIALIS for Once Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo-Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for CIALIS for Once Daily Use for BPH and One Study for ED and BPH
| Adverse Reaction | Placebo (N=576) |
Tadalafil 5 mg (N=581) |
| Headache | 2.3% | 4.1% |
| Dyspepsia | 0.2% | 2.4% |
| Back pain | 1.4% | 2.4% |
| Nasopharyngitis | 1.6% | 2.1% |
| Diarrhea | 1.0% | 1.4% |
| Pain in extremity | 0.0% | 1.4% |
| Myalgia | 0.3% | 1.2% |
| Dizziness | 0.5% | 1.0% |
Additional, less frequent adverse reactions (
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© Cialis Patient Information is supplied by Cerner Multum, Inc. and Cialis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
SL >Erectile Dysfunction (ED) Causes and Treatment See Slideshow
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